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510(k) Data Aggregation
(438 days)
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver.
The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.
The provided text is a 510(k) Summary for the Aulisa Oximeter Module (2nd Gen.). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the full study design and results of performance evaluations in the granular detail requested.
However, based on the information provided, here's an attempt to extract the relevant details for the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "The SpO2 accuracy data were calculated using the Accuracy root-mean-square (ARMS) and the results which indicated that the subject device had an ARMs less than 3 digits during steady-state conditions over the range of 70-100% were in compliance with the specified performance claimed by the manufacturer." This is the primary performance claim related to SpO2 accuracy.
| Acceptance Criteria (Metric) | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (ARMS) | Less than 3 digits | Less than 3 digits |
| SpO2 Range for Accuracy | 70-100% | 70-100% |
| Pulse Rate Accuracy | ± 3 digits (or ± 3%) | ± 3 digits (30-290 bpm) or ± 3% (30-290 bpm) |
| Pulse Rate Range for Accuracy | 30-290 bpm | 30-290 bpm |
| Electrical Safety | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Temperature and Humidity | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Atmospheric Pressure (Altitude) | Pass IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | Pass IEC 60601-1-2 | Pass |
| Performance (General) | Pass ISO 80601-2-61 | Pass |
| Mechanical Durability | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Pass ISO 10993-5, ISO 10993-10, ISO 10993-23 | Pass |
| Software V&V | Pass FDA Guidance | Pass |
| Security Testing | Pass FDA Guidance | Pass |
| Wireless Coexistence Testing | Pass ANSI C63.27 | Pass |
| Clinical Testing (General) | Pass FDA Guidance | Pass |
| Usability Testing | Pass FDA Guidance | Pass |
| Bench Testing | Pass Manufacturer's specifications | Pass |
| Durability and Performance | Pass Manufacturer's specifications | Pass |
| Battery Life Testing | Pass Manufacturer's specifications | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document only states "The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects." It does not specify the number of subjects (sample size).
- Data Provenance: The document does not explicitly state the country of origin. It describes the test as a "clinical evaluation," implying a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an oximeter, "ground truth" for SpO2 is typically established by arterial blood gas analysis, which does not involve experts in the same way as, for example, image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as the "ground truth" for SpO2 accuracy in oximetry is typically established by a direct comparison to a reference standard (e.g., co-oximetry of arterial blood samples), not by expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The Aulisa Oximeter Module is a device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic tool that requires human readers for interpretation. Its performance is evaluated against reference standards, not human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the SpO2 accuracy evaluation (against ISO 80601-2-61 and FDA Guidance) would be considered a standalone performance test of the device's ability to measure SpO2. The device directly measures and outputs these values, so its performance is inherently "standalone."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for SpO2 accuracy in oximetry studies is typically established using arterial blood gas analysis (specifically, co-oximetry) as the reference standard, allowing for precise measurement of arterial oxygen saturation. This is implied by the reference to ISO 80601-2-61, which outlines these methodologies.
8. The sample size for the training set
This information is not applicable/provided. This device is a hardware oximeter module that directly measures physiological signals and processes them to derive SpO2 and pulse rate. It does not appear to involve a machine learning model that would require a separate "training set" in the common sense of AI/ML development. Its "training" would be more akin to calibration and algorithm refinement based on engineering principles and physiological models.
9. How the ground truth for the training set was established
As per point 8, this is not applicable.
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(148 days)
The Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO2). The subject device consists of a selfcontained foot-worn sensor module (SM) and a portable, table-top wireless display unit (DU). It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements taken by the SM are wirelessly transmitted to the DU for display using Bluetooth technology. The subject device also provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System
Purpose: Measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Primarily for pediatrics and infants during non-motion and well-perfused conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Pulse Oximetry Accuracy (SpO2): Accuracy (Arms) below 3% over the range of 70%-100% SpO2 | Arms is below 3%, compliant with FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)]. |
| Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8 | Device complies with these standards. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Device complies with this standard. |
| Biocompatibility: Meet requirements of ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Biocompatibility evaluation conducted, including Cytotoxicity, Sensitization, and Irritation tests. (Implicitly passed as it supports substantial equivalence). |
| Software Verification & Validation: Documentation provided as recommended by FDA guidance. | Software verification and validation testing conducted and documentation provided. (Implicitly passed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): "Over 200 data points were collected."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the applicant is "Taiwan Aulisa Medical Devices Technologies, Inc." This suggests the clinical study could have been conducted in Taiwan or another location consistent with the applicant's operations.
- Retrospective or Prospective: "Clinical data were collected... to verify the accuracy of the subject device on healthy subjects over the range of 70%-100% SpO2 through controlled induced hypoxia." This indicates a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an oximeter, not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for SpO2 accuracy is established through controlled induced hypoxia measurements against a reference standard (likely arterial blood gas measurements, though not explicitly stated, this is the standard for pulse oximetry accuracy). Therefore, the concept of "experts establishing ground truth" in the context of interpretation (like radiologists for imaging) does not apply here. The expertise required would be in conducting the induced hypoxia study and accurate blood gas analysis.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for pulse oximetry accuracy is derived from physiological measurements (e.g., arterial blood gas analysis under controlled hypoxia), not subjective expert judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI assistance (e.g., radiologists reading medical images). The Guardian Angel Rx GA1001 is a vital sign monitoring system, not an AI-powered diagnostic imaging tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The clinical study described (measuring SpO2 accuracy through controlled induced hypoxia) is a standalone performance evaluation of the device. It assesses the device's ability to accurately measure SpO2 directly, without human interpretation as part of the primary measurement function. The performance metric "Arms is below 3%" directly reflects the algorithm's (and hardware's) accuracy compared to the reference standard.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was established through controlled induced hypoxia on healthy subjects. In the context of pulse oximetry, this typically involves comparing the device's SpO2 readings to simultaneously measured arterial oxygen saturation (SaO2) values obtained from arterial blood gas (ABG) analysis. The sO2 (and corresponding SaO2) values from the ABG are considered the "ground truth."
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. For hardware devices with embedded algorithms like pulse oximeters, the "training" (calibration and refinement of algorithms) typically happens during development and might use internal data or general physiological models. The provided study describes the validation/test set used for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about a distinct "training set" in the context of machine learning, the method for establishing its ground truth is not detailed. For traditional medical device algorithms, the "ground truth" for development and calibration would be established through established scientific principles, extensive physiological data, and potentially iterative testing against reference methods (like ABG) during the R&D phase.
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(116 days)
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The careqiver can review the historical data whenever needed.
The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU).
It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.
The provided text describes the acceptance criteria and a study for the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, which measures functional oxygen saturation (SpO2) and pulse rate.
Here's an organized breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device's accuracy was verified through a clinical study. The acceptance criterion for SpO2 accuracy is explicitly mentioned in relation to the FDA guidance.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Ams (Accuracy root-mean-square) less than 3 digits (70%-100% SpO2 range) as per FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)] | Ams is less than 3 digits, compliant with FDA guidance on Pulse Oximeters. |
| Pulse Rate | Not explicitly stated as an acceptance criterion in the provided text, but measured. | Pulse rate measurements were taken. (Specific accuracy value not provided within the criteria section in this document excerpt). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: "healthy adult subjects" (number not specified, but stated "Over 200 data points were collected").
- Data Provenance: The study involved "healthy adult subjects" and used "controlled induced hypoxia." The country of origin for the data is not specified within the provided text. It is a prospective study as it involved collecting new data on subjects under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts or their qualifications for establishing ground truth in this context. For pulse oximetry accuracy studies, the "ground truth" (reference measurement of arterial oxygen saturation, SaO2) is typically established through co-oximetry of arterial blood samples, not expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth for pulse oximetry accuracy is derived from direct physiological measurements (co-oximetry), not subjective expert judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not conducted. This device is a vital sign monitor, and its performance is evaluated based on the accuracy of its physiological measurements against a reference standard, not human interpretation of images or other data. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this type of device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, the clinical study directly assesses the standalone performance of the device (the oximeter) in measuring SpO2 and pulse rate against a reference standard, without human interpretation of the device's output to determine diagnosis. The Ams value reported represents the algorithm's performance.
7. Type of Ground Truth Used:
The ground truth used was established via physiological measurements during controlled induced hypoxia. While not explicitly detailed in this excerpt, for pulse oximeters, the gold standard for SpO2 "ground truth" is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples.
8. Sample Size for the Training Set:
The provided text does not specify a training set size. This type of device (an oximeter) typically relies on established physiological principles and signal processing algorithms derived from extensive research and development in pulse oximetry, rather than a "training set" in the machine learning sense for a new AI algorithm. While there's internal algorithm development, the document refers to a clinical study for verification of accuracy, not for training a model.
9. How the Ground Truth for the Training Set Was Established:
As no explicit training set is mentioned in the context of a machine learning model, this question is not fully applicable based on the provided text. The device's underlying technology and ground truth for its development would be based on the established physiological relationship between light absorption and oxygen saturation, validated through extensive physiological studies over decades of pulse oximetry development.
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